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Cholesterol Test Strips
EUDAMEDClass IVD General (EU MDR)
Ref OCHO-401/411Model cholesterol meter
Identity
- Trade Name
- Cholesterol Test Strips EUDAMED
- Device Name
- Cholesterol Test Strips EUDAMED
- Model / Reference
- cholesterol meter EUDAMEDOCHO-401/411 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936983155601 EUDAMED
- Basic UDI-DI
- B-06936983155601 EUDAMED
- EMDN Code
- W01010205 CHOLESTEROL EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Category: Total cholesterol lipid IVD, reagent
Cholesterol Test Strips by Hangzhou Alltest Biotech.Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06936983155601 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Alltest Biotech.Co., Ltd.
- EUDAMED SRN
- CN-MF-000010710
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 33a8cfea-6cd2-4202-b0ee-7e4bafb5b869 61 fields · synced Sep 17, 2026